Bloomberg News

Sanofi’s Genzyme Receives FDA Approval of Framingham Plant

January 24, 2012

(Updates with analyst quote in fourth paragraph.)

Jan. 24 (Bloomberg) -- Sanofi, the French drugmaker that acquired Genzyme Corp. last year, said U.S. regulators approved a new plant that will allow Genzyme to return to full supply of one of its products.

The Food and Drug Administration approved the Framingham, Massachusetts, facility for the production of Fabrazyme, a treatment for Fabry disease, Paris-based Sanofi said in an e- mailed statement today. The company announced approval by European Union regulators on Jan. 18.

Sanofi needs the capacity to return to normal supplies of Fabrazyme. A 2009 virus contamination at Genzyme’s manufacturing plant in Allston, Massachusetts, led to shortages of Fabrazyme and another drug, Cerezyme, which reduced revenue and drove the company’s shares down, leading to Sanofi’s $20.1 billion takeover last year.

“Genzyme was an important acquisition for Sanofi and today’s announcement shows its recovery is on track,” Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. in Paris, said in a telephone interview today. “Sanofi managed to keep its commitment. It’s important.”

Sanofi rose 0.7 percent to 55.84 euros at 9:11 a.m. in Paris.

Chief Executive Officer Chris Viehbacher said in a Jan. 11 interview he didn’t expect further delays in restoring supply of Genzyme’s rare-disease treatments, and that Sanofi would be “more or less back to full supply” of Genzyme’s products by the middle of the year.

Restore Supply

“With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year,” Genzyme CEO David Meeker said in today’s statement.

Genzyme will begin moving the most severely affected patients in Europe to a full dose of Fabrazyme this quarter, the company said. Beginning in March, all U.S. patients currently on therapy will return to full dosing, according to Sanofi.

Genzyme’s top-selling medicine is Cerezyme, a mass-produced version of a human enzyme missing in patients with the inherited illness Gaucher disease, which garnered $722 million in sales in 2010. The drug had sales of more than $1 billion in 2007 and 2008 before shortages caused by the plant contamination.

Viehbacher said in a Nov. 3 conference call with analysts that the approval of the Framingham plant by the FDA would allow Sanofi to shift production of Fabrazyme there, leaving Allston free to focus on making Cerezyme.

Moving Fabrazyme to Framingham and “simplifying” the Allston plant “would dramatically help” increase output of Cerezyme, Viehbacher said that day.

The purchase of Cambridge, Massachusetts-based Genzyme, the largest maker of medicines for rare genetic disorders, allowed Sanofi to gain innovative drugs that are less vulnerable to generic competition.

Fabry disease causes fatty substances to build up to harmful levels in the eyes, kidneys, nervous system, and cardiovascular system.

--Editors: Phil Serafino, Marthe Fourcade

To contact the reporter on this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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